Method for separating and purifying heparin sodium and heparan sulfate from heparin byproducts

A technology of heparan sulfate and heparin by-products, applied in the direction of medical preparations containing active ingredients, pharmaceutical formulas, drug combinations, etc., can solve the problems of difficult heparan sulfate, reduce resin life, loss, etc., to solve financial and material resources , not easy to settle, cost-saving effect

Active Publication Date: 2013-02-06
NANJING KING FRIEND BIOCHEM PHARMA CO LTD +1
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  • Summary
  • Abstract
  • Description
  • Claims
  • Application Information

AI Technical Summary

Problems solved by technology

However, due to the difficulty in separating the effective substances, these by-products are generally discarded or stored after heparin production, or simply processed, such as the traditional process is mainly to purify heparan sulfate and dermatan sulfate from heparin by-products, and heparin sodium discarded, resulting in a certain loss
Heparan sulfate and dermatan sulfate have similar properties, and it is difficult to purify heparan sulfate by conventional ion exchange chromatography and fractional precipitation with organic solvents
In

Method used

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Examples

Experimental program
Comparison scheme
Effect test

Embodiment 1

[0028] (1) raw material is the by-product 260kg that heparin sodium produces, and the optical rotation value that records is-34.5 °, raw material is dissolved in purified water, makes raw material concentration be 5% (g / mL), adds potassium acetate, makes the potassium acetate The content is 30%, adjust the pH to 6, and let stand at a temperature of 18-20°C for 24 hours.

[0029] (2) Collect the precipitate by centrifugation, dissolve it into a 5% (g / mL) solution, add potassium acetate to make the content of potassium acetate 30% (g / mL), adjust the pH to 6 with acetic acid, and set the temperature at 18-20°C Let stand for 24 hours.

[0030] (3) Collect the precipitate by centrifugation, dissolve it with purified water, add absolute ethanol to precipitate, collect the precipitate by centrifugation, dissolve it again with purified water, and precipitate with absolute ethanol. The precipitate was collected and dehydrated to obtain 18.6 kg of heparin sodium.

[0031] The measured...

Embodiment 2

[0038] (1) raw material is the by-product 254kg that heparin sodium produces, and the optical rotation value that records is-1.7 °, raw material is dissolved in purified water, makes raw material concentration be 15% (g / mL), adds potassium acetate, makes potassium acetate The content is 45%, adjust the pH to 5, and let stand at a temperature of 18-20°C for 48 hours.

[0039] (2) Collect the precipitate by centrifugation, dissolve it into a 15% (g / mL) solution, add potassium acetate to make the content of potassium acetate 45% (g / mL), adjust the pH to 5 with acetic acid, and set the temperature at 18-20°C Let stand for 48 hours.

[0040] (3) Collect the precipitate by centrifugation, dissolve it with purified water, add absolute ethanol to precipitate, collect the precipitate by centrifugation, dissolve it again with purified water, and precipitate with absolute ethanol. The precipitate was collected and dehydrated to obtain 36.6 kg of heparin sodium.

[0041] The measured op...

Embodiment 3

[0048] (1) The raw material is 197kg of by-products produced by heparin sodium, and the measured optical rotation value is 15.2 °. The raw material is dissolved in purified water to make the raw material concentration 20% (g / mL), and potassium acetate is added to make the content of potassium acetate to 60% (g / mL), adjust the pH to 7, and let stand at a temperature of 18-20°C for 72 hours.

[0049] (2) Collect the precipitate by centrifugation, dissolve it into a 20% (g / mL) solution, add potassium acetate to make the content of potassium acetate 60% (g / mL), adjust the pH to 7 with acetic acid, and set the temperature at 18-20°C Let stand for 72 hours.

[0050] (3) Collect the precipitate by centrifugation, dissolve it with purified water, add absolute ethanol to precipitate, collect the precipitate by centrifugation, dissolve it again with purified water, and precipitate with absolute ethanol. The precipitate was collected and dehydrated to obtain 34.2 kg of heparin sodium. ...

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Abstract

The invention discloses a method for separating and purifying heparin sodium and heparan sulfate from heparin byproducts. The method comprises the steps of dissolving raw heparin byproducts, adding potassium acetate to precipitate and separate heparin sodium, adding potassium acetate to precipitate heparin sodium after precipitating and dissolving heparin sodium, collecting a precipitate, dissolving and then conducting fractional precipitation repeatedly with anhydrous alcohol to prepare the heparin sodium with a higher purity, adding a benedict reagent and a saturated sodium hydroxide solution to supernate, centrifuging to obtain a solution containing the heparan sulfate, removing copper ions with a decoppering agent, adding active carbon to absorb the precipitate, decolorizing and filtering, and then absorbing and eluting with anion exchange resin to obtain the high-purity heparan sulfate by separation. According to the method, the high-purity heparin sodium and heparan sulfate can be separated again from the byproducts used for producing the heparin sodium, so that financial resources and material resources required for storing or discarding a large number of heparin byproducts can be saved, wastes can be changed into valuables, the byproducts are recycled, the cost is saved greatly, and a value is created.

Description

technical field [0001] The invention relates to a method for separating and purifying heparin sodium and heparan sulfate from heparin by-products, belonging to the field of mucopolysaccharide biopharmaceuticals. Background technique [0002] Heparin sodium is a mucopolysaccharide sulfate anticoagulant drug. In recent years, studies have proved that heparin sodium also has the effect of lowering blood lipids. Heparan sulfate is a subfraction of heparin, present in unfractionated heparin. Compared with heparin sodium, heparan sulfate has the advantage of moderate anticoagulant activity. Heparan sulfate is used for antithrombotic, anti-inflammatory, hypolipidemic, and renal protection of diabetic patients, and is the most researched mucopolysaccharide biochemical drug in recent years. [0003] A large number of by-products, i.e. heparin by-products, are produced in the process of producing heparin from the porcine small intestinal mucosa through ion exchange and fractional pr...

Claims

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Application Information

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IPC IPC(8): C08B37/10A61K31/715A61P7/02
Inventor 段艳冰辛妮王永毅
Owner NANJING KING FRIEND BIOCHEM PHARMA CO LTD
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